Systemic Lupus ErythematosusPhase 2NCT02660944

A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 2 study testing RSLV-132 in people with Systemic Lupus Erythematosus, run by Resolve Therapeutics at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: RSLV-132
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 16 sitesUnited States
Study dates: 3 Jan 2016to 10 Aug 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

CLASI score greater than or equal to 10 at Baseline
Positive for one or more RNA autoantibodies

Who cannot join

severe, active central nervous system (CNS) involvement at Screening;
severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol, or an estimated creatinine clearance of <30 mL/min);
use of cyclophosphamide within 3 months of the Baseline visit;
use of rituximab within 6 months of the Baseline visit;
use of belimumab within 3 months of the Baseline visit;
use of background medications within 1 month of Baseline in excess of: i. mycophenolate mofetil > 3 g/day; ii. azathioprine > 200 mg/day; iii. methotrexate > 25 mg/day; iv. hydroxychloroquine > 400 mg/day; v. prednisone (or equivalent) > 15 mg/day;

Show all 15Show fewer

use of an intravenous steroid "pulse" within 2 months of Baseline;
use of an intramuscular steroid injection within 1 month of Baseline;
change in SLE medications within 1 month of Baseline;
the presence of a clinically significant infection in the judgement of the Investigator within seven days prior to the receipt of the first dose of study drug;
positive viral load test for hepatitis B, C, or HIV at Screening;
participation in another clinical trial with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline;
positive pregnancy test at Screening or at Baseline;
female subjects currently breast feeding at Baseline;
inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

University of Colorado
Aurora, Colorado, 80045
DJL Clinical Research
Charlotte, North Carolina, 28210
Clinical Research of West Florida
Clearwater, Florida, 33765
Cleveland Clinic
Cleveland, Ohio, 44195
Metroplex Clinical Research Center
Dallas, Texas, 75231
TriWest Research Associates
El Cajon, California, 92020
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33309
Northwell Health/ Division of Rheumatology
Great Neck, New York, 11042
University of California San Diego
La Jolla, California, 92093
Valerius Research Center
Los Alamitos, California, 90720
Wallace Rheumatic Study Center
Los Angeles, California, 90048
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Alper Research
Naples, Florida, 34102
Vanderbilt University
Nashville, Tennessee, 37232
Temple University
Philadelphia, Pennsylvania, 19140
Accurate Clinical Research
Sugar Land, Texas, 77479

Other trials in United States

About this study

Official title: A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.

Conditions: Systemic Lupus Erythematosus
Being tested: RSLV-132, Placebo
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSLV-132Drug
RNase-Fc fusion protein
PlaceboDrug
Saline placebo

Study groups in NCT02660944
Study group	Role	What they receive
RSLV-132	Experimental	10 mg/kg RSLV-132 Receives: Drug: RSLV-132
Placebo	Placebo comparator	Saline placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
Mean change from baseline (from baseline to Day 85; or baseline to Day 169) in CLASI activity scores (Last Observation Carried Forward [LOCF] post censoring values).
The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
Measured: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169

Secondary outcomes (1)

Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
Percentage of participants achieving a 50% improvement in CLASI activity score at Day 85 and Day 169 (LOCF post censoring due to use of exclusionary medications)
Measured: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 201610 Aug 2020

First posted21 Jan 2016 (estimated)
Study start3 Jan 2016
Primary completion28 May 2020
Study completion10 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02660944
Sponsor's protocol ID: 132-03
Status last verified: Mar 2021
First submitted: 16 Jan 2016
Last updated: 10 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PubMed 33687069

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
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RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT02660944
Acronym / sponsor ID: 132-03
Conditions: Systemic Lupus Erythematosus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Resolve TherapeuticsIndustry (pharma, biotech, devices)
Study start: 3 Jan 2016 (actual)
Primary completion: 28 May 2020 (actual)
Study completion: 10 Aug 2020 (actual)
First posted: 21 Jan 2016 (estimated)
Results: Posted 10 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
RSLV-132	Experimental	Drug: RSLV-13210 mg/kg RSLV-132
Placebo	Placebo comparator	Drug: PlaceboSaline placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

CLASI score greater than or equal to 10 at Baseline
Positive for one or more RNA autoantibodies

Key exclusion criteria (15 listed)

severe, active central nervous system (CNS) involvement at Screening;
severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol, or an estimated creatinine clearance of <30 mL/min);
use of cyclophosphamide within 3 months of the Baseline visit;
use of rituximab within 6 months of the Baseline visit;
use of belimumab within 3 months of the Baseline visit;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RSLV-132RNase-Fc fusion protein	Drug	RSLV-132
PlaceboSaline placebo	Drug	Placebo

Primary outcome

Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
Time frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
Mean change from baseline (from baseline to Day 85; or baseline to Day 169) in CLASI activity scores (Last Observation Carried Forward [LOCF] post censoring values). The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.

1 secondary outcome

Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
Time frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169

Results and safety

Results posted to the registry on 10 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RSLV-132	42	25
Placebo	22	12

Primary outcome: Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.

Time frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169. Mean (Standard Deviation). Unit: Scores on a scale

Measure	RSLV-132 n = 42	Placebo n = 22
Day 85	-6.2 (6.7)	-6.5 (6.2)
Day 169	-6.2 (8.5)	-5.7 (7.0)

RSLV-132 vs Placebo: Mean Difference (Final Values): 0.37 (95% CI -3.42 to 4.15), p = 0.845, t-test, 2 sided
RSLV-132 vs Placebo: Mean Difference (Final Values): -0.48 (95% CI -4.66 to 3.70), p = 0.818, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 215 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RSLV-132	3 of 42 (7.1%)	36 of 42 (85.7%)	0 of 42
Placebo	5 of 22 (22.7%)	20 of 22 (90.9%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33687069Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Individual participant dataSharing planned: No

Related trials for Systemic Lupus Erythematosus

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Posada, Ph.D. study chair

Resolve Therapeutics

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RSLV-132 in people with Systemic Lupus Erythematosus, run by Resolve Therapeutics at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo. (time frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02660944, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.